510(k) Report

510(k) · Cleared

Cleared

Acufex Fixation Button; Retention Bar, Wedge

K896310510(k) TraditionalCleared Nov 20, 198919-day reviewClass I21 CFR 878.4930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Acufex Microsurgical, Inc. · KGS Retention Device, Suture

Cleared on Nov 20, 1989 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 20, 1989
Review
19 days
Class
Class I
Product code
KGS
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK896310 Acufex Fixation Button; Retention Bar, WedgeAcufex Microsurgical, Inc. · 1989
  2. Descendant · cites it directly · 1 of its ownK023963 Adhoc ClawFuture Medical Systems, Inc. · 2003
  3. Descendant · 2 generations on · 0 of its ownK024185 BiodhocFuture Medical Systems, SA · 2004

Most influential descendants

Showing 2 of 2 · See all
  • K023963Adhoc ClawFuture Medical Systems, Inc. · 2003 · cites it directly1descendant
  • K024185BiodhocFuture Medical Systems, SA · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896310Acufex Fixation Button; Retention Bar, WedgeAcufex Microsurgical, Inc.1989—
+1K023963Adhoc ClawFuture Medical Systems, Inc.2003—
+2K024185BiodhocFuture Medical Systems, SA2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
FIG. 1 — Lineage of K896310, 1989–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023963Adhoc ClawFuture Medical Systems, Inc.20031

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K023963 (Future Medical Systems, Inc., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KGS devices

KGS Retention Device, Suture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGS

FDA has decided no KGS device since 2007.

Median 510(k) review, days · KGS

Too few KGS 510(k)s in any year since 2007 to give a median.

Recalls per year · KGS

No recall names KGS since 2007.

Adverse event reports per year · KGS

3in 2025

2007: 262008: 152009: 62010: 12011: 12012: 42013: 62014: 22015: 12016: 12017: 42019: 12020: 32021: 12023: 112024: 22025: 3
2007high 26 (2007) · low 0 (2018)2025

MAUDE reports naming product code KGS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—026
20080—015
20090—06
20100—01
20110—01
20120—04
20130—06
20140—02
20150—01
20160—01
20170—04
20180—00
20190—01
20200—03
20210—01
20220—00
20230—011
20240—02
20250—03
20260—0—

More from Acufex Microsurgical, Inc.

78 FDA decisions under this applicant name. See the company

  • K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  • K961853Proline Fast Pass Arthoscopic Needle PasserAcufex Microsurgical, Inc. · 1996
  • K954246Acufex Endofix Absorbable Interference ScrewAcufex Microsurgical, Inc. · 1996
  • K952535Acufex Endobutton TapeAcufex Microsurgical, Inc. · 19962 recalls
  • K953276Acufex Tag Delivery SystemAcufex Microsurgical, Inc. · 1995

Recent decisions in KGS

The KGS category page

  • K030031Soft Tissue Anchoring WashersAccu-Speed, Incorporated · 2003
  • K020480RBMSmith & Nephew, Inc. · 20021 recall
  • K964935Suture LockSmith & Nephew Endoscopy, Inc. · 1997
  • K941740Acufex Rotator Cuff Fixation ButtonAcufex Microsurgical, Inc. · 1995
  • K930675Mitek Cone WasherMitek Surgical Products, Inc. · 1993

https://510kreport.com/device/K896310 · printed Nov 4, 2026

Cite this page

510(k) Report. “K896310: Acufex Fixation Button; Retention Bar, Wedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896310

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026